• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

www.cigarette-brands.com 5/29/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229  

MAY 29, 2014

Via Electronic Mail
 
 
To: 5227b95db07f575g@5225b4d0pi3627q9.privatewhois.net.
 
 
WARNING LETTER
 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.cigarette-brand.com, and determined that your cigarette products listed there are offered for sale to customers in the United States.  Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or  derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
                                                                                                                                    
FDA has determined that several of your cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally,  FDA has determined that several of your cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
You sell or distribute cigarette products that you describe on the website as being lights, or ultra lights, by referring to them as such in product labeling or advertising and adding the qualifiers “Lights” or “Ultra Lights,” to the product names. Specifically, our review of your website revealed that you sell or distribute products listed under the heading “LIGHTS CIGARETTES” and/or described as “Lights,” including, but not limited to: Bond Street Special Selection, Camel Black described as “Camel Black Super Slims 100s,” Chesterfield Classic Blue, Davidoff Gold, Dunhill Fine Cut described as “Dunhill Fine Cut Dark Blue,” Kent HDi Blue, Kiss Dessert mini, Lucky Strike Original Silver, Marlboro Gold, Parliament Aqua Blue, Richmond Cherry Gold described as “Richmond Cherry Gold Super Slims 100s,” Sobranie White Russian, West Black Compact, Winston Balanced Blue described as “Winston Blue,” Magna Balanced Blue, Pall Mall described as “Pall Mall Lights (Blue),” and Viceroy Blue. 
 
In addition, you sell or distribute cigarettes listed under the heading “ULTRA LIGHTS CIGARETTES” and/or described as “Ultra lights,” including, but not limited to: Bond Street Fine Selection, Camel Black described as “Camel Black mini,” Chesterfield described as “Chesterfield Classic Bronze,” Davidoff Blue, Dunhill Fine Cut described as “Dunhill Fine Cut Azure,” Kent HDi Silver, L&M Motion Blue described as “L&M Motion Blue (mini),” Marlboro Gold Prime Edge 100s, Parliament Silver Blue, Richmond Cherry 4, Sobranie described as “Sobranie Gold,” Vogue Lilas described as “Vogue Super Slims Lilas 100s,” West Fusion White, Winston XSence described as “Winston XSence Silver(mini),” Marlboro described as Marlboro Silver,” More Silver described as “More Subtle Silver,” Pall Mall Azure, and Viceroy Silver.
 
Additionally, you describe products you offer for sale on the website, http://www.cigarette-brand.com, as containing reduced levels of substances. Specifically, the website includes the claim, “Lower tar variants of Gauloises cigarettes are also available. They are sold in red and golden-white packets.” This claim is included on the Gauloises Brand product page and is in reference to the “Gauloises Blondes Red” and “Gauloises Blondes Yellow” cigarette products that are offered for sale on the website.
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your website uses the descriptor “Lights,” and “Ultra Lights,” or similar descriptors for the above listed products, and includes claims that your products contain a reduced level of a substance, these products are modified risk tobacco products. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
Flavored Cigarette Violations
 
Additionally,our review of the website, http://www.cigarette-brands.com,  revealed that you offer for sale the following cigarette products: “Aroma Rich Apple,” “Aroma Rich Rum Cherry,”  ““Kiss Mohito(mini),” “Kiss Super Slims Clubnichka 100s” (strawberry), “Kiss Super Slims Fresh Apple 100s,” “Richmond Cherry Gold Super Slims 100s,” “Richmond Cherry Super Slims 100s,” “Richmond Cherry 4,” and “Richmond Cherry,” which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Additionally, Dunhill brand cigarettes are described as being known for their “spicy flavor.” Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
 
[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.
 
As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).  Thus, your flavored cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, these cigarette products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their  labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum cherry, mohito, strawberry, cherry, or spice as a characterizing flavor of the tobacco products.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
 
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1400163, in your response and direct your response to the following address:
 
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850 
 
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
 
 
Via Electronic Mail
 
cc:
abuse@internet.bs
 
abuse@3nt.com